Impact on Mortality of a Strategy Including Continuous Positive Airway Pressure Plus High Flow Nasal Cannula Oxygen Therapy Versus High Flow Nasal Cannula Oxygen Therapy Alone in Patients With de Novo Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial.
Condition(s) studied
Investigational drug(s) / intervention(s)
HFNC: Patients assigned to the control group will be continuously treated by HFNC. HFNC will be initiated within one hour following randomization
CPAP and HFNC: Patients assigned to the intervention group will receive high flow nasal oxygen plus CPAP sessions
Study summary
De novo hypoxemic acute respiratory failure (hARF) is one of the main causes of intensive care unit (ICU) admission. In de novo hARF, intubation is associated with a dramatic increase in mortality rate. Compared to standard oxygen, the use of high-flow oxygen nasal cannula (HFNC) might be beneficial to prevent intubation and mortality, although the results of trials and meta-analyses are conflicting. Even with HFNC, the intubation rate remains high. This is the reason why adjunctive therapies, administered in addition to HFNC are needed.
Continuous positive airway pressure (CPAP) is one of these adjunctive therapies. CPAP provides high level of positive end-expiratory pressure that ensures lung recruitment, but without adding inspiratory pressure support, which prevents ventilator induced lung injury. In addition, as opposed to pressure support, CPAP is well tolerated during long periods of time. Therefore, applying CPAP in addition to HFNC may reduce intubation rate and in turn mortality rate.
The present trial will evaluate the impact on mortality of a strategy including continuous positive airway pressure plus high flow nasal cannula oxygen therapy versus high flow nasal cannula oxygen therapy alone in patients with de novo acute hypoxemic respiratory failure: a Prospective, Randomized Controlled Trial
Eligibility
Primary outcome measure(s)
- Mortality — 90 days
Time to death within the 90 days after randomization
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU Amiens-Picardie | Amiens | France | Not Yet Recruiting |
| CHU Angers | Angers | France | Not Yet Recruiting |
| Centre Hospitalier Victor Dupouy | Argenteuil | France | Not Yet Recruiting |
| Hôpital Avicenne | Bobigny | France | Not Yet Recruiting |
| Centre Hospitalier de Bourg-en-Bresse - Site de Fleyriat | Bourg-en-Bresse | France | Recruiting |
| Hôpital Louis-Mourier | Colombes | France | Not Yet Recruiting |
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | France | Not Yet Recruiting |
| Hôpital Henri-Mondor | Créteil | France | Recruiting |
| Centre Hospitalier de Dieppe - Site Pasteur | Dieppe | France | Recruiting |
| Hôpital François Mitterrand | Dijon | France | Recruiting |
| Hôpital André Mignot | Le Chesnay | France | Recruiting |
| Hôpital Bicêtre | Le Kremlin-Bicêtre | France | Not Yet Recruiting |
| Centre Hospitalier du Mans | Le Mans | France | Recruiting |
| Hôpital Salengro | Lille | France | Recruiting |
| Hôpital Édouard Herriot - Hospices Civils de Lyon | Lyon | France | Recruiting |
| Hôpital de la Croix-Rousse - Hospices Civils de Lyon | Lyon | France | Recruiting |
| Hôpital Saint-Joseph Saint-Luc | Lyon | France | Not Yet Recruiting |
| Hôpital Lyon Sud - Hospices Civils de Lyon | Lyon | France | Not Yet Recruiting |
| Hôpital Lapeyronie | Montpellier | France | Recruiting |
| CHU de Nantes | Nantes | France | Not Yet Recruiting |
| Hôpital Pasteur | Nice | France | Active Not Recruiting |
| Hôpital de l'Archet | Nice | France | Recruiting |
| Hôpital Saint-Antoine | Paris | France | Recruiting |
| APHP - hôpital Pitié-Salpêtrière | Paris | France | Recruiting |
| Hôpital Tenon | Paris | France | Recruiting |
| Hôpital la Milétrie | Poitiers | France | Not Yet Recruiting |
| Hôpital Pontchaillou | Rennes | France | Not Yet Recruiting |
| Hôpital Charles-Nicolle | Rouen | France | Recruiting |
| Nouvel hôpital civil | Strasbourg | France | Recruiting |
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06213168 on ClinicalTrials.gov ↗ ← All trials in France